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CTRI Number  CTRI/2021/09/036450 [Registered on: 13/09/2021] Trial Registered Prospectively
Last Modified On: 12/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Role of urinary NGAL and MCP-1 in predicting progression of diabetic kidney disease  
Scientific Title of Study   Role of Novel Biomarkers Urinary NGAL and MCP-1 in Predicting Progression of Diabetic Kidney Disease in Type 2 DM  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shankar Prasad Nagaraju 
Designation  Professor Head Department of Nephrology Kasturba Medical College MAHE Manipal 
Affiliation  Kasturba medical college Manipal 
Address  ROOM NUMBER 15 DEPARTMENT OF NEPHROLOGY KASTURBA MEDICAL COLLEGE MANIPAL ACADEMY OF HIGHER EDUCATION MADHAV NAGAR MANIPAL KARNATAKA
Kasturba medical college MADHAV NAGAR MANIPAL KARNATAKA
Udupi
KARNATAKA
576104
India 
Phone  9739905443  
Fax    
Email  shankarmmcmed@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shankar Prasad Nagaraju 
Designation  Professor Head Department of Nephrology Kasturba Medical College MAHE Manipal 
Affiliation  Kasturba medical college Manipal 
Address  ROOM NUMBER 15 DEPARTMENT OF NEPHROLOGY KASTURBA MEDICAL COLLEGE MANIPAL ACADEMY OF HIGHER EDUCATION MADHAV NAGAR MANIPAL KARNATAKA
Kasturba medical college MADHAV NAGAR MANIPAL KARNATAKA
Udupi
KARNATAKA
576104
India 
Phone  9739905443  
Fax    
Email  shankarmmcmed@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHILNA M S 
Designation  PhD Scholar  
Affiliation  Kasturba medical college Manipal 
Address  DEPARTMENT OF NEPHROLOGY KASTURBA MEDICAL COLLEGE MANIPAL ACADEMY OF HIGHER EDUCATION MADHAV NAGAR MANIPAL KARNATAKA
Kasturba medical college MADHAV NAGAR MANIPAL KARNATAKA
Udupi
KARNATAKA
576104
India 
Phone  9895530259  
Fax    
Email  shilna.s@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical Collage and hospital 
 
Primary Sponsor  
Name  Kasturba Medical college 
Address  Kasturba Medical College Manipal Academy of Higher Education Madhav Nagar Manipal 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr shankar prasad Nagaraju  Kasturba medical college hospital  Department of nephrology,kasturba medical college and hospital,Manipal
Udupi
KARNATAKA 		 9739905443

shankarmmcmed@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Clinically diagnosed with DKD as per KDIGO guidelines(CKD stage 1-3)based on CKD-EPI equation in Type 2 DM  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rapid progressors with eGFR decline of more than than 5ml/min /1.73m2 /year  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
a. Worsening of proteinuria/New onset of micro albuminuria/ macro albuminuria.  1 year 
 
Target Sample Size   Total Sample Size="145"
Sample Size from India="145" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
                       DKD prevalence rate is continuously rising globally and is the leading cause of end-stage renal disease, with a high mortality rate. Limited predictive value of Albuminuria and increased prevalence of heterogeneity of DKD emphasizes the need for novel biomarkers in predicting progression. Urinary NGAL & MCP-I are upcoming promising biomarkers in tubular injury and inflammation in predicting the progression and are non-invasive and easy to execute in the laboratory. This study evaluates biomarkers from three key pathogenic pathways of DKD progression to predict its prognostic value. This is a single-center Prospective Cohort study. Patients diagnosed with DKD visiting the department of nephrology and medicine OPD will be recruited for the study. Baseline demographic, clinical and laboratory data will be collected. Urine samples will be collected at the time of enrollment for NGAL and MCP-1 analysis.
Patients will be followed up every 3 months for 1 year prospectively for the DKD progression from the date of enrolment. Urine albumin and serum creatinine value will be calculated  during each follow-up.  eGFR will be calculated using serum creatinine values and CKD-EPI equation. The primary outcome measure will be rapid progressors (> 5ml/min /1.73m2 /year) and non-rapid progressors (< 5ml/min /1.73m2 /year) based on eGFR, and secondary outcome measure will be the worsening of proteinuria/new onset of  microalbuminuria/macroalbuminuria. Analysis of risk factors in rapid progressors including NGAL and MCP-1 will be done.  ROC analysis for NGAL and MCP-1 will be performed for optimum cutoff. 
 
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